Classifying SaMD can be tricky, so it's useful to have a few references!
Can't watch right now and rather read a quick summary? Here is a recap of what Joel shares in the video:
Hello. Joel here from the team at Proxima CRO.
Today we're going to walk through a few common examples of Software as a Medical Device or SaMD products, as well as some non examples to contrast the two. According to the FDA, SaMD is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
Let's talk through a few medical product examples that would be SaMD devices.
Software with a medical purpose that operates on a general computing platform such as a computing platform that does not have a medical intent. For example, software that diagnoses cancer, using an accelerometer that operates on the embedded processor of a consumer digital camera, software that is connected to a hardware medical device but is not needed by that hardware medical device to achieve its intended medical purpose and would not be considered an accessory to this hardware medical product. For instance, software that allows a commercially available smartphone to view images for diagnostic purposes obtained from an MRI medical device.
What software would not be considered SaMD? If the software is part of a hardware medical device or does not have a regulated medical purpose, it does not meet the definition of software as a medical device.
A few examples of non-SaMD products are software required by a hardware medical device to perform the hardware's medical device intended use, such as a mobile application required to operate a medical device. Software that relies on data from a medical device but does not have a medical purpose, such as software that encrypts data for transmission from a medical device.
Software that enables clinical communication and workflow, such as telemedicine, video conferencing software, and finally, software that monitors performance or proper functioning of a device for the purpose of servicing the device, such as software that monitors x-ray tube performance to anticipate the need for a replacement. If you are planning to submit an SaMD product to the FDA, it's important to work with a knowledgeable CRO team that has experiences with these types of devices.
Our team at Proxima can help you navigate this mission process and ensure your product gets the attention it deserves. Visit us at proximacro.com.